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EC number: 600-891-1 | CAS number: 1089-78-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 17 beta-Hydroxy-5(10)-estren-3-one
- EC Number:
- 600-891-1
- Cas Number:
- 1089-78-7
- Molecular formula:
- C18 H26 O2
- IUPAC Name:
- 17 beta-Hydroxy-5(10)-estren-3-one
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Kisslegg, Germany
- Age at study initiation: no data
- Weight at study initiation: males 3.3 – 3.6 kg, females 4.0 - 4.6 kg
- Housing: 1 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1-20.9
- Humidity (%): 61.0-65.0
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye remained untreated and served as control
- Amount / concentration applied:
- 0.1 mL of the test substance were applied, which corresponded to a mass of 40.6 to 48.2 mg of the test substance.
- Duration of treatment / exposure:
- test substance remained in the eye
- Observation period (in vivo):
- 4-5 days
- Duration of post- treatment incubation (in vitro):
- not applicable
- Number of animals or in vitro replicates:
- 2 males and 2 females
- Details on study design:
- Four rabbits (2 male, 2 female) each received a volume of 0.1 mL test substance into the conjunctival sac of the right eye. This volume, measured in a specially prepared syringe, corresponded to 40.6– 48.2 mg test substance. The left eye remained untreated and served as control. At first, only one animal was treated, as in case of severe intolerance reactions the other animals would not have been exposed for humane reasons. The other animals were treated one day later. During administration and observation on the administration day (first day of the test) the animals were kept in restraining cages for approximately 2 hours. No food or water was available during this time.
Clinical observation:
Conjunctivae, eyelids, cornea and iris were evaluated before administration, 0.5, 1 and 2 hours thereafter, and then every 24 hours until termination of the study. Clinical observation was performed in each animal as long as findings occurred. Evaluation of the local tolerance on the conjunctiva of the rabbits was performed according to the score system recommended for the EU (Annex to EEC guideline 92/69/EWG, dated 31 Jul 1992, for the 17th adaptation of the EEC guideline 67/548/EWG, B 5. Acute Toxicity (Eye irritation). Off J EEC, L383A, Luxembourg, 29 Dec 1992.). In addition, all other local findings at the eyes as well as all other reactions to treatment were recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.58
- Max. score:
- 3
- Reversibility:
- fully reversible within: max. 5 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.25
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritant / corrosive response data:
- According to the system of evaluation recommended for EU (Annex to EEC guideline 92/69/EWG, dated 31 Jul 1992, for the 17th adaptation of the EEC guideline 67/548/EWG, B 5. Acute Toxicity (Eye irritation). Off J EEC, L383A, Luxembourg, 29 Dec 1992.), the values of findings relevant for classification at the time-points 24, 48 and 72 hours after administration were 0 for cornea and iris for every single animal at each time point.
Conjunctivae (reddening): 24 h - 3 animals with the score 1 (slight) and 1 animal with the score 2 (moderate); 48/72 h - 3 animals with the score 0 (no reddening) and 1 animal with the score 1 (slight)
Conjunctivae (swelling): 24/48/72 h - 3 animals with the score 0 (no swelling) and 1 animal with the score 1 (slight) - Other effects:
- The treatment did not cause any effects on body weight gain.
Any other information on results incl. tables
Details about frequency, intensity and duration of the findings are to be taken from Table 1.
Table 1: Summary of local findings after single administration of the test substance in the rabbit eye. A/B = summation of positive findings/number of animals concerned. x-y = first - last day of occurence of a finding.
Right eye 0.1 ml test substance | ||||
male | female | |||
A/B | x-y | A/B | x-y | |
Conjunctiva | ||||
Reddening (all conjunctiva incl. conjunctiva sklerae) | ||||
- clear injection of a few vessels | 3/2 | 1 - 2 | 4/2 | 1 -4 |
-diffuse crimson, single vessels are difficult to notice | 5/2 | 1 -1 | 6/2 | 1 -2 |
Swelling (conjunctiva and third eyelid) | ||||
- slight (incl. membrana nicitans) | 3/2 | 1 -1 | 6/1 | 1 -4 |
- clearly with partial ectropium | 3/2 | 1 -1 | ||
- with half eyelid closure | 3/1 | 1 -1 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Remarks:
- in the opinion of the study director
- Executive summary:
A single conjunctival administration of the test substance (technical quality including impurities) into the conjunctival sac of the rabbit eye provoked slight irritation on administration day which decreased in severity from day 2 onwards and were fully reversible on day 5 after administration. Based on these findings, no irreversible effect is to be expected after contact of the human eye with the substance.
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